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ACCESS to Life, BIO for Hope www.accessbio.net www.accessbio.net

BIO for Hope - accessbio.net€¦ · Access Bio saves lives and instills hope through advanced in vitro technology for the early diagnosis of diseases. History Establishment of Access

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ACCESS to Life,

BIO for Hope

www.accessbio.netwww.accessbio.net

04 History

06 CEO’s Message

07 Core Value

08 Vision & Strategy

10 Products for LIFE

17 Technology for HOPE

20 Global Platform

22 Contact Information

Contents ACCESS to Life,

BIO for Hope

Life is precious regardless of nationality, race or religion.

Access Bio saves lives and instills hope through advanced

in vitro technology for the early diagnosis of diseases.

Access Bio will serve as a bridge connecting science and life to

promote health and wellbeing for all people.

Access Bio saves lives and instills hope through advanced in vitro technology for the early diagnosis of diseases.

History

Establishment of Access Bio, Inc.

U.S. Dept of Defense projects - Dengue, Scrub TyphusU.S. SBIR projects - Scrub Thphus, Leishmania

Top performance in WHO RDT product evaluation results (ROUND 1, 2, 3, 4)- Official publication of high quality mRDTsLanding an investment from STIC InvestmentEstablishment of a production facility in EthiopiaContracts to supply Malaria RDT - Ethiopia, Nigeria

G6PD RDT achieved accuracy of ≥ 95%World's first G6PD Biosensor developmentWorld's first G6PD POCT commercializationHighlighted presentation of G6PD RDTs at the APMEN conferenceWon contracts of Malaria RDTs-Kenya, Uganda, Nigeria

$4 million dollars malaria RDT order from KenyaAcquisition of a molecular diagnostic companyEstablishment of Korea R&D and production subsidiaryMalaria RDT long-term contracts with John Snow Inc. and UNICEF$7.8 million malaria RDT order from EthiopiaEthiopian subsidiary started productionListed on Korean Stock Exchange (IPO)

KFDA certification of exportability for G6PD Biosensor

2002 2006 2009 ~ 2011 2012 2013 2014

2014

2013

2012

2009 ~ 2011

2006

2002

www.accessbio.net 05 04 ACCESS to Life, BIO for Hope

www.accessbio.net 07 06 ACCESS to Life, BIO for Hope

“Each and every life is precious”A healthy life, free of illness, is a long-held wish in society. Guided by the basic principles of cherishing life and health for all people, Access Bio has been dedicated to the research, development and quality improvement of the medical diagnosis industry. Through the development of in vitro diagnostics technology, Access Bio has successfully commercialized products of outstanding quality to battle malaria and other diseases that pose a serious health threat across the globe. Since our inception in 2002, we have built a strong presence in the global market for the diagnostic testing of malaria and instilled hope for a healthy life among those suffering from this deadly disease.

“Quality acknowledged by the WHO”In accordance with the World Health Organization’s global fight against malaria, demand is steadily growing for high-quality rapid diagnostics tests (RDT) for prompt and accurate diagnosis. The superior quality of Access Bio’s CareStartTM has been verified through the malaria diagnostics kit testing by the U.S. Centers for Disease Control and Prevention upon request from the WHO. This has enabled Access Bio to forge partnerships with international agencies including the WHO, UNICEF, Global Fund, and MSF (Medecins Sans Frontieres, Doctors without Borders). Drawing from our solid footing in malaria diagnosis and accumulated R&D expertise, Access Bio strives to develop diagnostic tests in diverse fields and enhance the wellbeing and quality of life for people around the world.

“Global pioneer in diagnostic testing”As we look toward the future, Access Bio will not merely respond to the changing environment, but move forward with a proactive stance. With efficient processes and a dynamic culture, we will harness our competitive advantage to develop next-generation technologies and sustain growth. As a world leader in medical diagnosis, Access Bio is committed in promoting hope for a healthy life and garnering the trust of all stakeholders.

Thank you.

ACCESS to LifeGuided by the basic principles of cherishing life and health for all people, Access Bio is dedicated to the prevention and early diagnosis of infectious diseases. In addition to malaria diagnostic kits which have been recognized by the WHO (World Health Organization) and MSF (Medecins Sans Frontieres), Access Bio has also developed tests for G6PD deficiency, myocardial infarction, dengue fever and influenza. Our diagnostic products are saving lives across the globe.

BIO for HopeBased on convergence of bioengineering, information technology and nanotechnology, Access Bio is developing next-generation products for rapid and accurate diagnosis. Our research is shining a light of hope so that children everywhere can lead healthy lives free of disease and nurture their dreams.

The Trinity _ Corporate Social ResponsibilityDriven by the goal of promoting health for all people, Access Bio is committed to sharing the fruit of labor with all stakeholders. Internally, we promote a sense of pride and achievement by adhering to fair and transparent practices. At the same time, we strive to build trust with customers as a reliable partner and provide appropriate returns to our shareholders. At Access Bio, we firmly believe that fulfilling our social responsibilities holds the key to sustainable growth.

Young H. Choi President and CEO

CEO’s Message Core Value

Vision

Global pioneer in in vitro diagnostic technology

Promote health and wellbeing of mankind via quality diagnosis of diseases

Reinforce market presence and diversify

markets

Strengthen quality control and customer

management

Develop value-added products

Enhance sustainability of profits

Reinforce market footing in malaria diagnosis; launch new diagnostic products including

tests for G6PD deficiency, dengue fever, influenza and Strep A

Maintain stringent quality control; strengthen relationships

with customers including international agencies, non-profit

organizations, and retailers

Build a portfolio of value-added products based on cutting-

edge technologies in in vitro diagnostics

Reduce costs via product diversification, economies of

scale, and automation

Products for LIFEEven at this very moment, malaria is taking the precious lives of young children. CareStartTM is shining a light of hope for children suffering from malaria.

Facts on Malaria (Source: WHO World Malaria Report 2012)

• Three major infectious diseases are AIDS, tuberculosis, and malaria• 3 billion people in more than 100 countries are at risk of malaria infection• Every year, over 200 million people are infected with malaria, resulting in 650,000 deaths• Every 60 seconds, a child dies of malaria mostly in sub-Saharan Africa

Vision & Strategy

www.accessbio.net 11 10 ACCESS to Life, BIO for Hope

CareStartTM Malaria RDTAlong with AIDS and tuberculosis, malaria is one of the world’s three major infectious diseases. Malaria is caused by Plasmodium parasites and transmitted to people through the bites of infected mosquitoes. It is prevalent in sub-Saharan Africa and Southeast Asia where sanitary conditions and healthcare infrastructure are lacking. In order to prevent side effects and drug resistance caused by the abuse of antimalarials, there is growing emphasis on prevention and early diagnosis of malaria. Accordingly, demands have increased for rapid diagnostic tests (RDT) with proven sensitivity and accuracy.

◼ There are four Plasmodium parasites that cause malaria in humans, namely P. falciparum, P. vivax, P. malariae, and P. ovale. ◼ After infection, the parasites travel through the bloodstream to the liver where they multiply and are release back to the bloodstream before infecting red blood cells. Symptoms of malaria include fever, chills and vomiting. If untreated, malaria can lead to serious complications and even deaths. ◼ Common in Africa, P. falciparum is highly virulent and associated with high mortality rates.

◼ Cat # : G0111◼ Detect pLDH, sensitive for drug efficacy◼ Diagnose all 4 types of malaria (Pf, Pv, Po, Pm) infections

◼ Cat # : G0121◼ Detect pLDH◼ Diagnose all 4 types of malaria (Pf, Pv, Po, Pm) infections◼ Distinguish between Pf and other (Pv, Po, Pm) infections

◼ Cat # : G0141◼ Detect HRP2, very sensitive for Pf infection◼ Diagnose Pf infection

◼ Cat # : G0151◼ Detect pLDH◼ Diagnose Pf infection

◼ Cat # : G0131◼ Detect HRP2 (Pf) and pLDH (Pf, Pv, Po, Pm) ◼ Diagnose all 4 types of malaria (Pf, Pv, Po, Pm) infections◼ Distinguish between Pf and other (Pv, Po, Pm) infections

◼ Cat # : G0171◼ Detect HRP2 (Pf) and pLDH (Pv, Po, Pm)◼ Diagnose all 4 types of malaria (Pf, Pv, Po, Pm) infections◼ Distinguish between Pf and other (Pv, Po, Pm) infections◼ Distinguish mixed infection (Pf and other) from Pf infection

Access Bio offers an extensive lineup of 11 different malaria RDTs, including diagnosis of all 4 human malaria and pregnancy.

Pan Malaria RDT

Pf Exclusive RDT

Combo RDT

RDT for Malaria in Pregnancy ◼ Cat # : G0191

◼ Diagnose malaria infection and pregnancy ◼ Diagnose Pf infection

◼ Cat # : G0201◼ Diagnose malaria infection and pregnancy ◼ Diagnose all 4 types of malaria (Pf, Pv, Po, Pm) infections

Products for LIFE

CareStart TM Malaria pLDH(pf)

CareStart TM Malaria pLDH(pf/PAN)

CareStart TM Malaria HRP2(pf)

CareStart TM Malaria HRP2/pLDH(pf/PAN) Combo

CareStart TM Malaria HRP2/pLDH(pf/VOM) Combo

CareStart TM Malaria /Pregnancy(pLDH/HCG)CareStart TM Malaria /Pregnancy(HRP2/HCG)

CareStart TM Malaria pLDH(PAN)

◼ marked

◼ marked

◼ marked

◼ Cat # : G0161◼ Detect HRP2 (Pf) and pLDH (Pv) ◼ Diagnose 2 major types of malaria (Pf and Pv) infections◼ Distinguish between Pf and Pv infections◼ Distinguish Pf/Pv mixed infection from Pf single infection

◼ Cat # : G0231◼ Detect HRP2 and pLDH ◼ Diagnose HRP2-deleted Pf infection◼ Diagnose all 4 types of malaria (Pf, Pv, Po, Pm) infections◼ Distinguish Pf from other (Pv, Po, Pm) infections

CareStart TM Malaria HRP2/pLDH(Pf/Pv) Combo

CareStart TM Malaria Screen

◼ marked

◼ marked

◼ Cat # : G0181◼ Detect HRP2 and pLDH◼ Very sensitive for both markers◼ Diagnose HRP2-deleted Pf infection

CareStart TM Malaria HRP2/pLDH(pf)

◼ marked

◼ marked

◼ marked

www.accessbio.net 13 12 ACCESS to Life, BIO for Hope

Products for LIFE

CareStartTM G6PD True Point-Of Care Test for G6PD with > 99.9% Sensitivity* * WHO classification I & II

CareStart™ G6PD RDT is a visual screening test that identifies G6PD deficient patients using whole blood sample. It can also be a semi-quantitative assay in conjunction with a CareStart™ RDT reader.

◼ Catalog Number: G0223◼ Test Type: Qualitative point-of-care test◼ Assay Method: Visual dye colorization method◼ Interpretation: Normal vs. deficient ◼ Specimen: Whole blood◼ Specimen volume: 2 ㎕◼ Result Time: 10 min.◼ Package Size: 25 or 50 tests/box◼ Other Specifications: - Simple and easy to use - Fast and reliable - Broad range of assay temperature (18-32℃) - Room temperature storage - marked

Deficiency Normal

Results of Access Bio's G6PD Performance Test: Institute Pasteur, Cambodia

Cutoff Value(%) <30%

CareStart™G6PD RDT

Sensitivity (95% CI) 100%

Sensitivity (95% CI) 97%

◼ Source: November 2013. American Society of Tropical Medicine and Hygiene Annual Meeting.◼ Title: A field trial to evaluate the performance of a point-of-care diagnostic for screening G6PD

Deficiency in a falciparum and vivax malaria endemic area of Westem Cambodia.

Access Bio is preparing to introduce the world’s first commercial G6PD biosensor that enhances sensitivity and accuracy based on electrochemical analysis.

Glucose-6-Phosphate Dehydrogenase (or G6PD) is one of key enzymes that helps the body process carbohydrates and turn them into energy. G6PD deficiency is a genetic disorder, resulting in no or low G6PD activity. People with G6PD deficiency should not take primaquine, a malaria drug, and other painkillers because it could cause serious illness, brain damage, or even death via high oxidative stress. Now, more countries are implementing G6PD screening as a part of their newborn screening program.

CareStart™ G6PD Biosensor gives quantitative measurement of total G6PD enzyme activity in just 4 minutes, which is suitable for neonatal and adult screening purposes.

CareStart TM G6PD Biosensor◼ Catalog Number: TGB-E00181◼ Test Type: Quantitative point-of-care test◼ Measurement: Precise measurement of total G6PD activity◼ Specimen: Whole blood◼ Specimen volume: 5 ㎕◼ Result Time: 4 min.◼ Package Size: 25 strips/pack◼ Other Specifications: - Assay Method: Automatic blood loading - Internal sensor for temperature calibration - Internal memory storing up to 1,000 test results

Applications ◼ Screening for congenital adrenal hyperplasia (CAH)

mutations using allele-specific primer extension (ASPE) and bead-array hybridization

◼ Detection of the 10 major point mutations and the 8 bp deletion at Chromosome 6p21.3

◼ Detection of a large deletion between CYP21A1P and CYP21A2

Features◼ Semi-quantitative test with bead array for point mutation

and agarose electrophoresis for a large deletion◼ Approximately 8 hours from DNA extraction to data

reporting

www.accessbio.net 15 14 ACCESS to Life, BIO for Hope

Products for LIFE

Dengue Fever RDTAccess Bio’s Dengue fever RDT enables speedy and accurate diagnosis of dengue fever infection based on immunochromatography of NS1 and IgG/IgM detection. Dengue fever ROSGENETM combines immunochromatography with gene amplification for enhanced sensitivity and accuracy.

Myocardial Infarction RDT Prevention and early diagnosis is crucial for myocardial infarction (MI) which refers to the necrosis of myocardial muscle. The occurrence of arrhythmia after MI can be fatal. Access Bio’s myocardial infarction RDT can be used for early diagnosis in place of tests involving costly equipment such as the electrocardiogram, echocardiogram, and CT scan.

Pregnancy and Ovulation Test Pregnancy and ovulation can be easily diagnosed with a urine sample.

Influenza A & B RDTThe use of immunochromatography to distinguish between influenza types A and B enables the best course of treatment depending on the symptoms. With outstanding sensitivity and specificity, Access Bio’s Influenza RDT is expected to generate new demand around the world, and It will facilitate Access Bio’s diversification into global markets.

Influenza A & B ROSUSTM

ROSUSTM improves the immunochromatographic method with the adoption of fluorescent europium for enhanced signal-to-noise ratios, which eventually lead to higher sensitivity and specificity. Therefore, our Influenza A & B and ROSUSTM kits enable rapid and accurate diagnosis of influenza A and B.

Strep A RDTAccess Bio’s Strep A RDT detects Streptococcus pyogenes Aureus Group A infection based on immunochromatography and requires just a small amount of pathogen antigens. It is a cost-competitive strip test providing higher sensitivity and specificity than the earlier version.

Other Products

Products in the

Pipeline

Access Bio is pursuing product and market diversification through development of a wide range of diagnostic tests.

HPV Genotyping Test◼ CareStart™ HPV Genotyping kit-T

Catalog Number : MVT-N10081◼ CareStart™ HPV Genotyping kit-O

Catalog Number : MVO-N10081

HPV Screening Test◼ CareStart™ HPV genotyping kit-PNA

Catalog Number : MVA-N10081

CareStartTM HPV Genotyping/Screening Test

CareStartTM CAH Genotyping/ Screening Test

Genotyping (Luminex)26 HPV subtypes (18 High, 8 Low)

Yes No

Allele-specific detection(Amplified target DNAs with different sizes)

General Screening for HPV infection

www.accessbio.net 17

Technology for HOPE A healthy life is a long-held wish in society. CareStartTM is paving the way toward healthy and hopeful future.

Extraordinary progress is being made in the field of medical diagnosis thanks to the convergence of bio, information, nano and electronic technologies. With a firm commitment to sustainable values, Access Bio continues to pioneer advances in in vitro diagnosis to protect precious lives, bringing hope to future generations.

Technology for HOPE

■In production ■ R&D completed ■ R&D in progress ■ R&D planned

RapidChromatography

Gene Amplification

Single strip enzyme

activation assay

Nanogold technology

ROSUSTM

ROSGENETM

G6PD RDT

Dengue fever RDT

TRF Influenza

Malaria, Myocardial Infarction

Quantitative analysis of G6PD

Virus gene detection

Dengue virus

Influenza A & B Strep A

Research & DevelopmentAccess Bio is combining immunochromatography with nanotechnology to develop diagnostic tests with enhanced sensitivity and accuracy. We have added G6PD and dengue fever RDT kits to our existing lineup of products for malaria and myocardial infarction. In addition, research is underway for the development of tests to diagnose strep throat and influenza. Our R&D pipeline also includes ROSUSTM, which labels antibodies and antigens with europium to increase sensitivity and detection range, and ROSGENETM that combines genetic diagnosis with RDT technology for shorter testing times.

PCR

Bead Array

MolecularDiagnostics

HPV

HPV

CAH

Key Patents

Countries of Patent

Registration

International Certification

Patents and CertificationsThe quality of CareStartTM RDT has been proven in numerous clinical trials of international agencies and research institutes (WHO, Pasteur Institute, MSF, University of Toronto, Malaria Consortium, etc.). This has elevated the brand value of Access Bio products. Currently, Access Bio is preparing to launch the world’s first G6PD biosensor based on electrochemical analysis.

Adding to its expertise in immunochemical diagnostics, Access Bio advances its technological frontline by the convergence of electrochemical and genetic diagnostic technologies.

◼ Unique technology for sample extraction and storage◼ Chromatography-based measuring system◼ Nucleic acid detection system◼ A single-pad lateral flow system for enhanced liquid flow

◼ ISO 13485:2003 (quality management systems in the field of medical devices including in vitro diagnostics)◼ CE (compliance with the European Union in vitro diagnostics directive 98/79/EC)◼ FDA Certificate of Exportability (compliance with the U.S. FDA GMP guidelines and product stability standards)◼ FDA 510(K) (U.S. FDA notification for stability and performance of diagnostic tests)

◼ U.S.A.◼ Europe◼ Japan

◼ China◼ Canada◼ Korea

www.accessbio.net 19 18 ACCESS to Life, BIO for Hope

Technology for HOPE

Unique Design

Access Bio’s Genotyping Platform Technology

◼ SBS

5' 3'

↙Bulge

◼ Regular Primer

5' 3'

SBS(Specific-Bulging-Specific Oligonucleotide)

SBS is a unique primer designed for MULTIPLEX PCR. It allows amplification of multiple target sequences in a single reaction with high sensitivity and specificity.

Innovative Technology

◼ ~ 45℃(Low Temperature) ◼ ~ 65℃(High Temperature)

5'

(O)3' 5'

(O)3'

5'(O)

3'

5'

(O)3'

5'

3'

(X)

5'

3'(X)

1 PCR in 2-Step Amplification

SBS primers amplify multiple target analytes simultaneously in a single tube using step-wide increase of temperature.

www.accessbio.net 21 20 ACCESS to Life, BIO for Hope

With technology and quality recognized by international organizations and global research institutes, Access Bio is pioneering the field of in vitro diagnosis.

Global Platform

Business Partners R&D Partners Production Network

█ International Organization: WHO (World Health Organization), UNICEF (United Nations Children’s Fund), UNDP (United Nations Development Program), UNOPS (United Nations Office for Project Services), MSF (Medecins Sans Frontieres), KOICA (Korea International Cooperation Agency), NMCP (National Malaria Control Programme), CHAI (Clinton Health Access Initiative), etc.█ Government: 55 nations including Kenya, Nigeria, Madagascar, Cambodia, Ethiopia, India, etc. █ Private Corporation: Premier Medical Corporation, Microgene, SGV Medical Supplies, etc.

█ U.S.A.: U.S. Department of Defense, U.S. Army Research Institute, U.S. Naval Research Laboratory, Tulane University, PATH, etc.█ Korea: Medisensor, KIAT (Korea Institute of Advancement of Technology), KCDC (Korea Centers for Disease Control & Prevention), etc.█ Others: Pasteur Institute (Cambodia), Shoklo Malaria Research Unit (SMRU, Thailand), Eijkman Institute (India), Kintampo Health Research Center (Ghana), etc.

█ Access Bio, Inc., U.S.A. (Headquarters in New Jersey)█ Access Bio, Inc., Korea█ Access Bio, Inc., Ethiopia

ABIABK

ABE

Access Bio, Inc., U.S.A. (Head office)Address : 65 Clyde Rd. Suite A, Somerset, NJ 08873Tel : +1-732-873-4040 Fax : +1-732-873-4043e-mail : [email protected]

Access Bio, Inc., Korea Address : 401 Yangcheon Rd., Gangseo-Gu, Seoul, KoreaTel : +82-70-4739-3656 Fax : +82-2-6010-6110e-mail : [email protected]

Access Bio, Inc., Ethiopia (Production subsidiary)

Address : Kebele 16, New Addis Ababa, Yeka Sub-City, EthiopiaTel : +251-924-337517e-mail : [email protected]

Contact Information

22 ACCESS to Life, BIO for Hope

ACCESS to Life, BIO for Hope

ACCESS BIO